Comparison of the Effectiveness of Preurodynamic Single Dose of Levofloxacin With Posturodynamic Levofloxacin for Three Days on the Incidence of Urinary Tract Infections
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Number of Participant With Urinary Tract Infection
研究概览
简要总结
This study aims to compare the effectiveness of preoperative single dose of levofloxacin with postoperative levofloxacin for three days on the incidence of urinary tract infections (UTI) after urodynamic examination.
详细描述
This study aims to compare the effectiveness of preoperative single dose of levofloxacin with postoperative levofloxacin for three days on the incidence of urinary tract infections (UTI) after urodynamic examination. This study uses a randomized single-blind trial design to compare the proportion of posturodynamic UTI in the group receiving preurodynamic single-dose levofloxacin with the group receiving three days - once daily of Levofloxacin posturodynamic. The target population is patients who undergo urodynamic examination at the RSUPN dr. Cipto Mangunkusumo, Siloam ASRI Hospital, and Persahabatan Hospital during the given time.
of the study. The total sample size in this study was determined based on a two-proportion analytical sample calculation formula with type 1 error of 5% and type 2 error of 80%. On the fourth posturodynamic day, urinalysis and urine culture were performed to determine the diagnosis of UTI. To analyze the association between UTI and the treatment group, the chi-square test was used. Results were considered statistically significant if p < 0.05.
The expected results are data on the comparison of the incidence of UTI after urodynamic examination in the group given a single dose of levofloxacin and levofloxacin for three days post-examination.
The incidence of UTI in the group receiving a single preurodynamic dose of levofloxacin compared to the group receiving levofloxacin for three days posturodynamics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study uses a single-blinded design because the outcome assessed in this study is urinalysis which is the objective outcome. The urinalysis evaluator is blinded to the drug regimen obtained by the research subjects.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/female patients > 18 years who have indications for urodynamics
- •Willing to participate in research
排除标准
- •Allergy to levofloxacin
- •History of taking antibiotics in 1 month • Pregnant
- •Uncontrolled DM
- •Use a urinary catheter
- •Having a UTI before urodynamics, based on clinical symptoms and urine examination results
- •Refuse to participate in research
研究组 & 干预措施
Pre-urodynamic Levofloxacin
Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
干预措施: Pre-urodynamic Levofloxacin (Drug)
Post-urodynamic Levofloxacin
Levofloxacin 500 mg will be given for 3 days, once daily, post-urodynamic examination
干预措施: Post-urodynamic Levofloxacin (Drug)
结局指标
主要结局
Number of Participant With Urinary Tract Infection
时间窗: 4 days after urodynamic
Urinary tract infection is defined based on the result of urinalysis in which one of the following condition present : leukocyes \> 5 / high power field, bacteria positive, nitrite positive, and/or positive leukocyte esterase
次要结局
未报告次要终点
研究者
dr. Harrina Erlianti Rahadjo, Sp.U(K), PhD
Prof. dr., Sp.U(K), PhD
Indonesia University
